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目的对奥沙利铂脂质体进行质量评价,建立奥沙利铂脂质体包封率的测定方法。方法采用凝胶微柱离心法分离游离药物与脂质体,以HPLC测定奥沙利铂的药物含量,计算脂质体的包封率。结果奥沙利铂浓度在0.02~1 mg·mL-1内线性关系良好(r=0.999 9)。3批次奥沙利铂脂质体的包封率分别为56.6%,57.5%,60.0%。结论该方法简便、迅速,可准确测定奥沙利铂脂质体的包封率。
OBJECTIVE To evaluate the quality of oxaliplatin liposomes and to establish the method for determining the encapsulation efficiency of oxaliplatin liposomes. Methods Free drugs and liposomes were separated by gel micro column centrifugation. The drug content of oxaliplatin was determined by HPLC and the entrapment efficiency of liposomes was calculated. Results The linearity of oxaliplatin was 0.02 ~ 1 mg · mL-1 (r = 0.999 9). The encapsulation efficiency of 3 batches of oxaliplatin liposomes were 56.6%, 57.5% and 60.0%, respectively. Conclusion The method is simple and rapid and can accurately determine the encapsulation efficiency of oxaliplatin liposomes.